Kornimate/medical-research-clean huggingface dataset:
lifestyle intervention in primary health care - the björknäs study

Conditions: Hypertension; Type 2 Diabetes; Obesity; Dyslipidemia

Summary: the purpose of this study is to determine whether a short group intervention programe aiming at lifestyle changes at a local health centre can improve risk factors for cardiovascular disease

successfully transferring the findings of expensive and tightly controlled lifestyle intervention programmes to the primary care setting is necessary if such knowledge is to be used for disease prevention at the population level. therefore, our objective was to evaluate the efficacy of a lifestyle intervention programe in the primary health care setting, targeted at patients with moderate- to high-risk of cardiovascular disease according to cardiovascular risk factor levels, physical activity and quality of life ratings. randomised controlled trial with follow-up at 3, 12, 24 and 36 months, carried out in a primary health care centre in northern sweden. a total of 151 middle-aged men and women, with hypertension, dyslipidemia, type 2 diabetes or obesity were enrolled. the subjects were randomised to an intervention (n = 75) or control group (n = 76). 120 subjects completed the three-year follow-up. the intervention was based on the protocols used in the finnish diabetes prevention study (dps) and the u.s diabetes prevention program

Eligibility criteria:
inclusion criteria: * patients from one single health care centre with a diagnosis of: * typ 2 diabetes, * hypertension, * obesity or * dyslipidemia exclusion criteria: * coronary heart * disease, * stroke, * tia, * bp \>180/105, * dementia; or * severe psychiatric disease

Keywords: primary prevention health promotion diet exercise risk factors randomized controlled trial
drug use investigation for imigran tablet

Conditions: Migraine Disorders

Summary: the study is designed to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy of sumatriptan tablet, and to discuss the need of special investigation and postmarketing clinical study. a special focus was placed on the investigation of occurrence of "ischaemic heart disease-like events including arrhythmia, angina pectoris, and myocardial infarction" in the present study.


Eligibility criteria:
inclusion criteria: * subjects with migraine disorders exclusion criteria: * subjects with hypersensitivity to sumatriptan * subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina * subjects with history of peripheral vascular disorder * subjects with history of cerebrovascular disorder or transient ischemic attacks * subjects with uncontrolled high-blood pressure * subjects with severe hepatic function disorder * subjects taking ergotamine, ergotamine derivative containing product, or 5-ht1b/1d agonist * subjects taking monoamine oxidaze inhibitor or use within 2 weeks of discontinuation
psychosocial patterns and prognosis in patients with heart failure

Conditions: Systolic Heart Failure; Diastolic Heart Failure

Summary: this prospective observational study is designed to confirm the prognostic and economic impact of depression in ambulatory patients with systolic or diastolic heart failure, to explore the impact of other psychosocial patterns such as type d personality, anxiety disorders, locus of control, perceived social support, anger, hopelessness, and to evaluate potential pathophysiological and behavioral pathways.

studies suggest that depressive symptoms may be associated with a worse prognosis and higher costs of care in patients with chronic heart failure in some populations, but such data in a french population are missing. on the other hand, little is known of the impact of other psychosocial dysfunction whereas the pathophysiology of this association remains hypothetical. main objective: to confirm the impact of depressive symptoms on cardiovascular death in ambulatory heart failure patients other objectives: * to study the impact of depressive symptoms on sudden death, non cardiovascular death, and hospitalization rates; * to study the role of other psychosocial patterns or personality traits such as anxiety disorders, locus of control, perceived social support, anger, hopelessness, optimism and type d personality in cardiovascular and total mortality; * to study the interaction with patient behaviors (drug compliance, addictions); * to explore some pathophysiological pathways (chronic inflammation and chronic loss of myocytes), * and to evaluate the impact of psychosocial distress on health care costs. design: multicenter observational study with a minimum of 2 year follow up population: 700 ambulatory patients, aged above 18 y.o., with acute heart failure within the last 24 months methodology: * psychosocial patterns and personality traits are assessed using validated self-administered questionnaire; use of the beck depression index in this population is validated against the montgomery \& asberg depression rating scale evaluation * cardiac condition is evaluated at pre-defined time period by b-natriuretic peptide levels, echocardiography and 6'-walk test end-point criteria: * primary : rate of cardiovascular death * secondary : rate of total mortality and sudden death, rate of rehospitalization for heart failure and for any cause, total and specific health care costs.

Eligibility criteria:
inclusion criteria: * age above 18, * acute heart failure within the last 24 months * stable cardiovascular condition for at least 2 weeks * non hospitalized, non institutionalized patient, * french speaking and reading, exclusion criteria: * non inclusion criteria : * curable cardiomyopathy, cardiomyopathies associated with systemic illnesses (lupus...), neurodegenerative or pulmonary illnesses, or hypertrophic/restrictive cardiomyopathy * unstable cardiovascular condition * heart transplant and hemodialysis patient

Keywords: heart failure psychosocial factors depression patient compliance
the efficacy of pd-1 antibody sintilimab on early-stage multiple primary lung cancer with ground glass density.

Conditions: Multiple Primary Lung Cancers

Summary: a single-center,prospective interventional study to explore the efficacy of pd-1 antibody sintilimab on early-stage multiple primary lung cancer patients with ground-glass nodules in ct scan.

this study is a single-center,prospective interventional clinical study, all subjects enrolled are multiple primary lung cancer patients with ground-glass density in ct scan.the samples plan for the study was 36 cases.the enrolled patients will receive intravenous infusion of sintilimab 200mg every 3 weeks up to 4 cycles, and the efficacy will be evaluated after cycle 2 and 4 using recist criteria (version 1.1 ).

Eligibility criteria:
inclusion criteria: * two or more ground-glass lesions (pure ground glass or partially solid) presented in the ct scan of lung that cannot be operated simultaneously * there was at least one lung cancer lesion with a diameter of 1-3cm confirmed pathologically or by multidisciplinary team. * excluding lymph nodes and distant metastasis through imaging * ecog ps 0-1 * vital organ functions meet the following requirements: 1)the absolute count of neutrophils ≥1.5×109/l 2)platelet ≥90×109/l 3)hemoglobin ≥9g/dl 4)serum albumin ≥3g/dl 5)thyroid stimulating hormone (tsh) ≤uln (if abnormal, t3 and t4 levels should be examined at the same time; if t3 and t4 levels are normal, they can be included in the group) 6)bilirubin ≤uln 7)alt and ast≤1.5 uln 8)akp≤ 2.5uln or less 9)serum creatinine ≤1.5 uln or creatinine clearance ≥60ml/min * subjects volunteered to participate in this study and signed informed consent, with good compliance. exclusion criteria: * non-calcified lesions with diameter more than 3mm are presented * the presence of any active autoimmune diseases or a history of autoimmune diseases * those who have used other drugs in clinical study within 4 weeks before the first time of drug use * severe allergic reaction to monoclonal antibody * heart clinical symptoms or diseases are not well controlled * subjects with congenital or acquired immune deficiency (such as hiv infection) or active hepatitis * according to the researcher's judgment, the subjects have other factors that may lead to the forced termination of this study

Keywords: ground-glass nodule ground-glass density
topical calcipotriol versus narrowband ultraviolet b in treatment of alopecia areata

Conditions: Alopecia Areata

Summary: alopecia areata is a common condition. this study investigated the efficacy of calcipotriol versus narrow band ultraviolet b in treatment of alopecia areata and their effects on serum vitamin d3 levels.


Eligibility criteria:
inclusion criteria: * alopecia areata of scalp exclusion criteria: other causes of alopecias including scarring alopecia, androgenic alopecia, telogen effluvium autoimmune diseases, pregnant and lactating females

Keywords: alopecia areata calcipotriol narrow band-uvb vitamin d3
the acc preclinical research platform for precision oncology

Conditions: Solid Tumor; Hematologic Neoplasms

Summary: the acc preclinical research platform for precision oncology is a retrospective and prospective observational study focused on the implementation and validation of the application of pdcm (patient derived cancer models) generated from tissues or cells of patients with neoplastic disease, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.

this is a retrospective and prospective observational study, focused on the implementation and validation of the application of pdcm, generated from tissue or cells of patients, including paediatric patients, with solid and haematological malignancies, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments. an up-to-date database of all pdcms available at the participating italian hospitals will be generated and enriched with new models generated during the course of the project. the sharing of models and procedures between the different hospitals will facilitate their molecular and phenotypic characterisation, also in parallel with the tumours of origin, as well as their validation as tools for testing the efficacy of drugs for precision medicine. by establishing common workflows and standards and performing cross-validation experiments it is planned to build a network of reference centres as a resource for drug screening on 2d and 3d models.

Eligibility criteria:
inclusion criteria: * patients, including paediatric patients, with solid and haematological malignancies for whom tissue or tumour cell material is available. exclusion criteria: * none
clinical outcomes and safety: a registry study of ilaris (canakinumab) patients

Conditions: Cryopyrin-associated Periodic Syndromes (CAPS); Familial Cold Autoinflam Syn (FCAS); Muckle-wells Syn (MWS); Neonatal Onset Multisystem Inflam Disease (NOMID)

Summary: the purpose of this observational study is to collect additional information regarding long-term safety and effectiveness of ilaris in the treatment of caps patients in clinical practice.


Eligibility criteria:
inclusion criteria: * patients receiving ilaris (canakinumab) at the time of enrollment as part of medical care exclusion criteria: * local regulations in some locations may exclude patients who receive ilaris for a non-approved indication * other protocol-defined inclusion/exclusion criteria may apply

Keywords: cryopyrin-associated periodic syndromes(caps) cias1 protein nlrp3 protein human cryopyrin protein familial cold autoinflammatory syndrome(fcas) muckle-wells syndrome(mws) neonatal onset multisystem inflammatory disease(nomid) nalp3 canakinumab interleukin-1(il-1)
prograf-advagraf cross over conversion study

Conditions: Kidney-Pancreas Transplantation

Summary: the present study is aimed at evaluating the impact of a switch from prograf to advagraf on renal function, trough tacrolimus levels, drug-related adverse effects and adherence in stable recipients of kidney-pancreas transplants. mpa pharmacokinetics will also be evaluated. the results of this study have the potential to change current practice.

tacrolimus (prograf ©) has become part of the standard of care for patients receiving solid organ transplants and is part of the immunosuppressive protocol used by kidney-pancreas transplant recipients at university health network (uhn). tacrolimus is associated with several toxicities, and as a result, careful therapeutic drug monitoring of tacrolimus is a key component of post-transplant management. trough serum concentrations of tacrolimus are measured routinely and are used to guide dosing. tacrolimus trough levels are known to correlate with total drug exposure. the prograf formulation of tacrolimus has a fairly short serum half-life and must be dosed twice daily to maintain therapeutic serum concentrations. this results in two high peak levels each day which have been shown to correlate with toxicity. thus, avoidance of high peaks may be desirable to minimize tacrolimus toxicity. advagraf is a new preparation of tacrolimus that is formulated to provide similar drug exposure to tacrolimus but with a once daily dosing regimen, which avoids the 2 daily high tacrolimus peaks observed with prograf. in this way, it is hoped that advagraf may provide similar therapeutic efficacy as prograf but with fewer adverse effects. in addition, the simpler dosing regimen is expected to enhance patient adherence. tacrolimus has also been shown, along with many other drugs, to have a variable impact on mycophenolate acid (mpa) pharmacokinetics. there are currently few data on whether advagraf impacts mpa pharmacokinetics to the same or a lesser degree than prograf. eligible kidney-pancreas recipients will be recruited and after obtaining informed consent, randomized to continue their current total daily prograf dosage or switch to the equivalent once daily dose of advagraf. patients will continue randomized therapy for 12 weeks and will then cross over to the opposite therapy for another 12 weeks. patients will be followed and maintained on the same medication designated at week 24. bloodwork results, adherence and aes (adverse events) will be assessed.

Eligibility criteria:
inclusion criteria: * recipient of kidney and pancreas transplant * aged 18 years or older * 12 months or more since time of transplant * stable allograft function (creatinine \ 40 ml/min) * targeted to a tacrolimus trough level of 5-10 ug/ml that has been stable during the prior 3 mo. exclusion criteria: * episode of acute rejection within 6 months of screening

Keywords: renal transplantation kidney transplantation pancreas transplantation tacrolimus advagraf prograf drug adherence
biomarkers of cognitive impairment in blood cells

Conditions: Mild Cognitive Impairment Due to Alzheimer's Disease; Dementia Due to Alzheimer's Disease (Disorder)

Summary: the aim of this study is to identify transcriptomic biomarkers in blood cells to diagnose early cognitive impairment. this would allow preventing the development of severe pathologies, such as alzheimer disease. in addition, this project will analyse the influence of adiposity, obesity, nutritional habits and physical activity on cognition.

blood cells constitute a minimally invasive material, which is presented as potentially suitable for addressing the identification of clinical diagnostic biomarkers. this study will compare gene expression in blood cells of patients with various degrees of cognitive alteration (mild cognitive impairment due to alzheimer's disease and dementia due to alzheimer's disease) compared to control individuals, to identify early biomarkers of impaired cognition. the availability of non-invasive early biomarkers of cognitive dysfunction is highly relevant in the field of public health, from the point of view of being able to prevent or delay the onset and/or progression of dementia and other cognitive disorders. in addition, it is intended to establish the association between the biomarkers identified with nutritional imbalances and increased adiposity/obesity.

Eligibility criteria:
1. control group inclusion criteria: * age between 55-80 years * absence of cognitive symptoms * normal neuropsychological examination, (clinical dementia rating, cdr = 0) exclusion criteria: * any disease that could influence their cognitive performance or blood cell parameters. 2. group with mild cognitive impairment due to alzheimer's disease (mci group) inclusion criteria: * age between 55-80 years * established diagnosis of mci * cognitive deficit of 1.5 standard deviation in at least one of the neuropsychological tests performed, with no relevant functional repercussion (functional activities questionnaire, faq\<7 and cdr≤0.5) 3. group with dementia due to alzheimer disease (ad) inclusion criteria: * age between 55-80 years * established diagnosis of alzheimer's disease * cdr ≥ 0.5 and positive ad markers in cerebrospinal fluid

Keywords: mild cognitive impairment alzheimer disease blood cells adiposity nutrition
assessment of the impact of gadolinium injection on the measurement of the qsm signal

Conditions: White Matter Disease

Summary: patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. if they agree, they will perform an mri without injection to obtain the qsm then perform the mri with injection that was prescribed to them as part of the care, then they will perform a second time the mri without injection to obtain the qsm. they will also answer a short questionnaire documenting their previous exposure to gadolinium.

patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. if they agree, they will perform an mri without injection to obtain the qsm then perform the mri with injection that was prescribed to them as part of the care, then they will perform a second time the mri without injection to obtain the qsm. they will also answer a short questionnaire documenting their previous exposure to gadolinium.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * with an inflammatory cns pathology * to benefit as part of care from an mri with injection of gadolinium * consent to participate in the study * beneficiary of a social protection scheme exclusion criteria: * pregnant or breastfeeding woman * patient benefiting from a legal protection measure * patient having performed more than 3 mri exams with gadolinium injection during his life secondary exclusion criteria : * motion artifact not allowing image interpretation * patient who has not completed one of the following sequences: t1 anatomical, flair, or qsm pre-gadolinium injection. secondarily excluded patients will be replaced up to a maximum of 25 patients.
a brief intervention to reduce suicide risk in military service members and veterans- study 1

Conditions: Suicide Risk | Patient

Summary: the investigators propose to evaluate suicide assessment and follow-up engagement: veteran emergency treatment (safe vet) which is currently being implemented in 4 va ed/urgent care units across the united states (portland va medical center (vamc), denver vamc, manhattan vamc, and philadelphia vamc).

background: in 2009, a novel clinical demonstration project entitled suicide assessment and follow-up engagement: veteran emergency treatment (safe vet) was initiated as a potential standard of care for suicidal veterans who receive treatment at veterans affairs (va) emergency departments (ed). safe vet is designed to attenuate suicide risk by helping veterans manage suicidal thoughts and behaviors, and adhere to prescribed clinical care; thereby promoting resiliency and increased capacity to cope with suicidal states. objectives: using a quasi-experimental design, the aim of this study is to compare the effectiveness of the safe vet intervention versus enhanced usual care (e-care)on the following: 1) the proportion of patients who attempt suicide within 6 months of index emergency department (ed) visit; 2) the severity of suicide ideation within 6 months after index ed visit; 3) the proportion of patients who attend \> 1 outpatient mental health or substance abuse treatment appointments within 30 days following index ed visit; and 4) the degree of suicide-related coping for attending treatment during the 6 month period. methodology: six hundred veterans, up to 300 per condition (safe vet or e-care), who meet inclusion/exclusion criteria will be enrolled. e-care sites are as follows: long beach vamc, bronx vamc, milwaukee vamc, and san diego vamc. all subjects will participate in an approximately 1-hour long baseline assessment battery (index ed visit) by phone, and will be contacted by phone at approximately 1, 3, and 6 months after the index ed visit to complete follow-up measures. medical records will also be reviewed to determine va health service usage in the six-month period after study enrollment.

Eligibility criteria:
inclusion criteria: veterans will be enrolled who: 1. have received the safe vet intervention in va safe vet eds or treatment-as-usual in e-care eds; 2. aged 18 years or older; 3. identified as being at risk for suicide based upon presenting complaints and/or the assessment of an ed clinician; 4. able to provide 2 contacts with telephone numbers for tracking purposes; and 5. able to provide a home/residential/shelter address where the participant resides and either a home, cellular, or other telephone number where the participant can be reached. exclusion criteria: veterans will not be enrolled if they are: 1. unable to read and understand english; 2. unable or unwilling to give informed consent as determined either by the referring va ed clinical staff or research personnel (see mini quiz below); and/or 3. admitted to the va inpatient psychiatric unit from the ed.